Regulatory Resources & Updates

Guidance documents, regulatory updates, and reference materials covering CDSCO, EU MDR/IVDR, US FDA, ISO standards, and more β€” curated for medical device and healthcare professionals.

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Showing 12 resources
Date Title / Description Category Type Download
Jun 2025
Medical Devices Rules 2017 β€” Consolidated TextCDSCO consolidated MDR 2017 including all amendments up to date
CDSCO / India
Regulation
May 2025
Wholesale Licence (MD-42) β€” Application GuidanceStep-by-step checklist for wholesale distributor licence under MDR 2017
CDSCO / India
Guidance
May 2025
Import Licence (MD-14) β€” Application ChecklistDocument requirements and process for medical device import licence
CDSCO / India
Checklist
Apr 2025
Investigational Device Permission (MD-26) β€” OverviewRequirements and pathway for investigational device permission under MDR 2017
CDSCO / India
Guidance
Mar 2025
EU MDR 745 β€” Summary of Key RequirementsOverview of essential requirements under EU Medical Device Regulation 2017/745
EU MDR / IVDR
Summary
Feb 2025
EU IVDR 746 β€” Classification & Transition TimelinesIVD classification rules and updated transition timeline guidance
EU MDR / IVDR
Guidance
Jan 2025
Post-Market Surveillance β€” PMS / PMCF / PSUR RequirementsPractical guidance on post-market surveillance obligations under EU MDR
EU MDR / IVDR
Guidance
Dec 2024
US FDA 510(k) β€” Submission Pathway OverviewKey requirements and process for 510(k) premarket notification submissions
US FDA
Guidance
Nov 2024
FDA QMSR / 21 CFR 820 β€” Key Changes SummaryComparison of QMSR against legacy QSR and alignment with ISO 13485
US FDA
Summary
Oct 2024
ISO 13485:2016 β€” Key Clauses Reference GuideQuick reference to ISO 13485:2016 clause requirements and audit focal points
ISO Standards
Reference
Sep 2024
ISO 14971 β€” Risk Management for Medical DevicesOverview of risk management process requirements and documentation expectations
ISO Standards
Reference
Aug 2024
Global Regulatory Landscape β€” Medical Devices Overview 2025Comparative overview of key regulatory frameworks: India, EU, USA, Japan, Brazil
General
Article